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Job Title Manager 2 – MSTG Non Orals
Business Unit
R&D1 Regulatory Affairs
Job Grade
G11A
Location
Vadodara
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Job Description
- To support for commercial troubleshooting/remediation/Market complaints for Non-Oral manufacturing sites US/EU/Row/Domestic)
- To support for timely investigation/execution and to resume commercial manufacturing and to meet market/ sales requirement.
- Executions of assigned DMAIC/DMADV projects. Co‐ordination and guidance to CFT for way forward. Review and approval of Investigation protocols and reports and sharing to site to meet compliance
- To lead Investigations of manufacturing sites which are referred to R & D at level 3 for evaluation and root cause analysis as a part of R &D Central investigation team.
- To provide technical support, during any stage of commercial manufacturing, as required by site (QC/ QA or Production). Technical support may include, but not limited to, review of CAPA or support for manufacturing site related query response.
- To collect data on intimation of failure OOS/OOT/Market complaints by site.
- To review site investigation report, product/method development reports, historical data trending, applying six sigma tools i.e .prioritization tools & technique, and statistical analysis.
- Planning and execution of investigational hypothesis and generation of analytical data at ADD as part of investigation/hypothesis study.
- Preparation of technical report of hypothesis study/investigation.
- Communication and discussion with site for root cause and for suitable CAPA and participation with CFT discussions with sites. Close co-ordination with CIT- ADD , FR&D, ADD Characterization team, manufacturing QA, Operation etc. to meet KPI such as TAT less then 30 days.
- Prioritization of refer issues from site and conducting meetings for the same. Maintain CIT Tracker and update to leadership weekly.
- To provide suggestions to manufacturing sites for improvement in process or analytical method to improve product robustness.
Preference will be given to candidate who have following experience and skills:
- Exposure/Experience to Non-Oral dosage form with excellent command on sterile unit operations and analytical techniques.
- Root cause analysis tools
- Statistical data evaluation
NA
Job Requirements
Educational Qualification
Graduate : M.Pharm
Experience
Tenure : Minimum 8 – 12 years of experience
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
